BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1812454 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-06143
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 19, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS UNABLE TO ADJUST STIMULATION WITH OR WITHOUT ANTENNA ATTACHED. THE AMPLITUDE WAS AT 5.0 V WITH ONE ANODE AND ONE CATHODE (BI-POLAR) AND BACK TO (B)(6) 2010 PT HAD THE DEVICE SET TO OVER 8.0 V. IT WAS FURTHER REPORTED THAT THE PT BATTERY HAD EXPIRED AND WAS REPLACED (B)(6) 2010. FOLLOWING REPLACEMENT SHE FELT STIMULATION AT AN AMPLITUDE SETTING OF 2.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention IMPLANTED:| LEAD: MODEL 3093, LOT # V168016| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT # NJD074191N